Improving Primary Care to Prevent Childhood Obesity
Primary Purpose
Overweight in Preschool Age Children, Risk of Overweight in Preschool Age Children
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
To change structure and roles of primary care teams to optimize prevention of obesity
Sponsored by
About this trial
This is an interventional prevention trial for Overweight in Preschool Age Children focused on measuring Chronic Care Model, Obesity, Overweight, Children, Body Mass Index, Primary Care
Eligibility Criteria
Inclusion Criteria:
- Age 2.0 through 5.9 years receiving primary care in a multi-site group practice
- BMI > 95th percentile for age and sex, or 85th - 95th percentile if at least one parent is overweight
Exclusion Criteria:
- Child currently enrolled in a formal weight management program
- Child is in foster care
- Chronic conditions that may limit our ability to measure height and weight or that may interfere with their growth, physical activity, or dietary recommendations
Sites / Locations
- Harvard Vanguard Medical AssociatesRecruiting
Outcomes
Primary Outcome Measures
Body mass index (BMI) at 1 year.
Secondary Outcome Measures
Television viewing behaviors at 1 year post intervention.
Sugar-sweetened beverages intake at 1 year post intervention.
Fast food intake at 1 year post intervention.
Full Information
NCT ID
NCT00377767
First Posted
September 15, 2006
Last Updated
September 15, 2006
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Harvard School of Public Health (HSPH)
1. Study Identification
Unique Protocol Identification Number
NCT00377767
Brief Title
Improving Primary Care to Prevent Childhood Obesity
Official Title
Improving Primary Care to Prevent Childhood Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2009 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators
Harvard School of Public Health (HSPH)
4. Oversight
5. Study Description
Brief Summary
To determine the extent to which a clinical intervention based on the Chronic Care Model (CCM), compared with the usual care control condition, results in a smaller age-associated increase in body mass index (BMI) over a 1 year intervention (primary outcome) and a 1 1/2-year follow-up period.
Detailed Description
Overweight in the preschool age group is prevalent, increasing, and of consequence. During the last 30 years in the U.S., the prevalence of overweight among youth has dramatically increased. Overweight in young children is associated with later overweight, with childhood conditions such as hyperlipidemia, hypertension, and type II diabetes, and with higher morbidity and mortality in adulthood.
Along with the long-term risks associated with overweight in the preschool age group, there come unique opportunities to intervene and alter the subsequent course of health and disease for these individuals. These regular visits allow both detection of elevated BMI levels and opportunities for intervention.
The overall goal of this research is to assess a comprehensive, innovative, primary care practice change intervention to prevent obesity among children age 2 through 5 years at elevated risk of obesity. To achieve this goal, we will conduct a cluster-randomized controlled trial in 10 pediatric practices of Harvard Vanguard Medical Associates, a large multi-site group practice in eastern Massachusetts with a track record of research collaboration.
We will randomize five health centers to the intervention condition, and five health centers to the control (usual care) condition. The intervention will consist of state-of-the-science approaches to changing dietary, activity, and inactivity behaviors among the children.
The intervention period will be 1 year, followed by a 1 1/2 year maintenance follow-up period. Frequency of visits will be every 6 weeks for the first 6 months, and every 6 months after that. Participating families will complete a telephone-administered interview at baseline and all follow-up timepoints. There will be 3 types of measurements: 1) measurements made by the clinical staff that will also be used for outcomes in the research study (only height and weight); 2) measurements made by clinicians for feedback during counseling sessions, which will not be used for study outcomes; and 3) measurements made by the research staff for study outcomes and processes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight in Preschool Age Children, Risk of Overweight in Preschool Age Children
Keywords
Chronic Care Model, Obesity, Overweight, Children, Body Mass Index, Primary Care
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
500 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
To change structure and roles of primary care teams to optimize prevention of obesity
Primary Outcome Measure Information:
Title
Body mass index (BMI) at 1 year.
Secondary Outcome Measure Information:
Title
Television viewing behaviors at 1 year post intervention.
Title
Sugar-sweetened beverages intake at 1 year post intervention.
Title
Fast food intake at 1 year post intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 2.0 through 5.9 years receiving primary care in a multi-site group practice
BMI > 95th percentile for age and sex, or 85th - 95th percentile if at least one parent is overweight
Exclusion Criteria:
Child currently enrolled in a formal weight management program
Child is in foster care
Chronic conditions that may limit our ability to measure height and weight or that may interfere with their growth, physical activity, or dietary recommendations
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine H Hohman, MPH
Phone
617-509-9869
Email
katherine_hohman@hphc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Price, MPH
Phone
617-509-9873
Email
sarah_price@hphc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Gillman, MD
Organizational Affiliation
Department of Ambulatory Care and Prevention/Harvard Pilgrim Health Care/ Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harvard Vanguard Medical Associates
City
Boston
State/Province
Massachusetts
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
24472122
Citation
Wright DR, Taveras EM, Gillman MW, Horan CM, Hohman KH, Gortmaker SL, Prosser LA. The cost of a primary care-based childhood obesity prevention intervention. BMC Health Serv Res. 2014 Jan 29;14:44. doi: 10.1186/1472-6963-14-44.
Results Reference
derived
PubMed Identifier
21997144
Citation
Hohman KH, Price SN, Sonneville K, Rifas-Shiman SL, Gortmaker SL, Gillman MW, Taveras EM. Can the Internet be used to reach parents for family-based childhood obesity interventions? Clin Pediatr (Phila). 2012 Apr;51(4):314-20. doi: 10.1177/0009922811423310. Epub 2011 Oct 12.
Results Reference
derived
PubMed Identifier
21464376
Citation
Taveras EM, Gortmaker SL, Hohman KH, Horan CM, Kleinman KP, Mitchell K, Price S, Prosser LA, Rifas-Shiman SL, Gillman MW. Randomized controlled trial to improve primary care to prevent and manage childhood obesity: the High Five for Kids study. Arch Pediatr Adolesc Med. 2011 Aug;165(8):714-22. doi: 10.1001/archpediatrics.2011.44. Epub 2011 Apr 4.
Results Reference
derived
PubMed Identifier
20847735
Citation
Taveras EM, Hohman KH, Price SN, Rifas-Shiman SL, Mitchell K, Gortmaker SL, Gillman MW. Correlates of participation in a pediatric primary care-based obesity prevention intervention. Obesity (Silver Spring). 2011 Feb;19(2):449-52. doi: 10.1038/oby.2010.207. Epub 2010 Sep 16.
Results Reference
derived
Learn more about this trial
Improving Primary Care to Prevent Childhood Obesity
We'll reach out to this number within 24 hrs